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The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.

UK Announces No-Deal Brexit CE Mark Equivalent

The UK announced its post-Brexit, UK-specific product marking for certain marketed goods should the country depart the EU without agreeing on a deal.

The UK Conformity Assessed (UKCA) marking applies to certain products that are described in new guidance, “Trading Goods Regulated Under the ‘New Approach’ if There’s No Brexit Deal.”

The government said that most products currently covered by the CE Mark will fall under the UKCA marking’s scope. The requirements for the new marking will be the same as those that currently apply to CE Marking.